AS 3

Dosage Form: injection, solution
Additive Solution Formula 3

AS-3 100 mL Catalog # 777965-000

Canada DIN 02324393

Intended for use only with Trima and Trima Accel automated red blood cell apheresis devices and Atreus Whole Blood Processing System. See Operator's Manuals for additional information and complete usage instructions.

Sterile. Non-pyrogenic. Do not use unless the solution is clear and the container is intact and undamaged. Rx only.

Single use container.

Caution: Not for direct intravenous infusion.

Recommended storage

Room temperature.

Avoid excessive heat. Protect from freezing.

Each 100mL contains:

Dextrose Monohydrate USP	1.10   g
Sodium Citrate Dihydrate USP	0.588 g
Sodium Chloride USP	0.410 g
Monobasic Sodium Phosphate Monohydrate USP	0.276 g
Citric Acid Monohydrate USP	0.042 g
Adenine USP	0.030 g
In Water for Injection USP

Lot

Expiry Date

Manufactured for CaridianBCT, Inc., Lakewood CO 80215

by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

Dist. in Canada: CaridianBCT (Canada), Inc., 4 Robert Speck Pkwy,

Ste. 1500, Mississauga, ON, Canada L4Z1S1

777965-054

PRINCIPAL DISPLAY PANEL - 100 mL Label

Additive Solution Formula 3 AS-3

6 x 6 x 100mL units

Catalog # 777965-000

Intended for use only with Trima and Trima Accel automated red blood cell

apheresis devices and Atreus Whole Blood Processing System. See Operator's

Manuals for additional information and complete usage instructions.

Sterile. Non-pyrogenic. Do not use unless the solution is clear and

the container is intact and undamaged. Rx only. Single use

container.

Caution: Not for direct intravenous infusion.

Recommended storage: Room temperature.

Avoid excessive heat. Protect from freezing.

Each 100mL contains:

Dextrose Monohydrate USP	1.10   g
Sodium Citrate Dihydrate USP	0.588 g
Sodium Chloride USP	0.410 g
Monobasic Sodium Phosphate Monohydrate USP	0.276 g
Citric Acid Monohydrate USP	0.042 g
Adenine USP	0.030 g
In Water for Injection USP

Lot

Expiry Date

Manufactured for CaridianBCT, Inc., Lakewood CO 80215

by Ivex Pharmaceuticals, Larne, BT40 2SH, UK.

Dist in Canada: CaridianBCT (Canada), Inc., 4 Robert Speck Pkwy,

Ste. 1500, Mississauga, ON, Canada L4Z1S1

Canada DIN 02324393

777965-064

AS   3 dextrose monohydrate, sodium citrate, sodium chloride, sodium phosphate, monobasic, monohydrate, citric acid monohydrate and adenine  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 14537-966 Route of Administration INTRAVENOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dextrose Monohydrate (Dextrose) Dextrose Monohydrate 1.1 g  in 100 mL Sodium Citrate (Sodium Cation) Sodium Citrate 0.588 g  in 100 mL Sodium Chloride (Sodium Cation) Sodium Chloride 0.41 g  in 100 mL Sodium Phosphate, Monobasic, Monohydrate (Sodium Cation) Sodium Phosphate, Monobasic, Monohydrate 0.276 g  in 100 mL Citric Acid Monohydrate (Ascorbic Acid) Citric Acid Monohydrate 0.042 g  in 100 mL Adenine (Adenine) Adenine 0.03 g  in 100 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 14537-966-10 100 mL In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA001214	05/29/2002

Labeler - CaridianBCT, Inc. (233649834)

Establishment
Name	Address	ID/FEI	Operations
CaridianBCT, Northern Ireland, Ltd. (dba Ivex Pharmaceuticals)		233649834	MANUFACTURE, STERILIZE, LABEL, ANALYSIS

Revised: 04/2010CaridianBCT, Inc.